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HIV/AIDS

Preclinical Master Contract

NIAID has placed a high priority on the development of safe and effective HIV vaccines for worldwide evaluation and use. A Preclinical Master Contract has been put in place to aid the preclinical development of promising vaccine candidates from the research laboratory to the clinic. This contract offers an array of resources to facilitate development of a promising candidate into a testable product. Resources are available to accomplish three basic functions:

Manufacture GMP pilot lots of vaccine for testing in humans, or GLP/reagent grade vaccine for testing in nonhuman primates

Perform tests for safety, immunogenicity and other preclinical testing of GMP produced candidates

Preparation of Food and Drug Administration (FDA) submissions leading up to human trials